The United States on December 22 authorized Pfizer Inc.’s antiviral Covid-19 pill for people ages 12 and older at risk of severe illness, the first oral and at-home treatment as well as a new tool against the fast-spreading Omicron variant.
Researchers globally produce hundreds of thousands of studies annually. It can be difficult to know if at some time in the future they will be the foundation for a disease cure or a technology such as CRISPR that revolutionizes medicine. But many are exciting for what they point to or how they spike the imagination. BioSpace reviews 10 of the more compelling research stories of 2021.
Novavax Inc.’s Covid-19 vaccine is effective in generating an immune response against the Omicron variant, according to early data published on December 22, suggesting that the U.S. drugmaker’s existing Covid-19 vaccine can help combat the new Omicron variant.
Shares of Takeda Pharmaceutical fell after the company announced the U.S. Food and Drug Administration rejected the New Drug Application for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis.
The U.S. Food and Drug Administration authorized the emergency use of Pfizer Inc.’s Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate Covid-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The U.S. Food and Drug Administration placed a clinical hold on Gilead Sciences’ use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV and HIV pre-exposure prophylaxis (PrEP).
Novartis is expanding the company’s position in gene therapy and retinal diseases with the $1.5 billion acquisition of UK-based ocular gene therapy company Gyroscope Therapeutics.
Older adults taking Bayer AG’s blockbuster blood thinner pill Xarelto for a common type of irregular heart rhythm had significantly higher rates of serious bleeding and stroke compared to those taking rival pill Eliquis, a U.S. study showed.
Novartis and BeiGene bookended 2021 with collaborative deals. In January, Novartis licensed the China-based company’s checkpoint inhibitor, tislelizumab. On December 20, the Swiss pharma giant announced the licensing of the late-stage TIGIT inhibitor ociperlimab to bolster Novartis’ immunotherapy pipeline.
Moderna Inc. said on December 20 that a booster dose of the company’s Covid-19 vaccine appeared to be protective against the fast-spreading Omicron variant in laboratory testing and that the current version of the shot would continue to be its “first line of defense against Omicron.”
